FDA.reportPublic FDA data

Portex

Primary DI
20351688047851
Brand
Portex
Company
ICU MEDICAL, INC.
Model
4988-17/27
Published
2017-01-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
BSPNEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K993619000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K993619000CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCKSims Portex, Inc.2000-04-28BSP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10351688047854PackageGS110In Commercial Distribution
20351688047851PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1035168804785410351688047854
2035168804785120351688047851

GMDN Terms#

Term, Definition table
TermDefinition
Epidural anaesthesia set, non-medicatedA collection of devices intended for the administration of an analgesic or anaesthetic agent (not included) to the epidural space for the management of pain. It includes a needle and/or a catheter with additional procedural devices (e.g., syringe, dressings, guidewire, introducer), and may be intended for single- or continuous-administration. It is not intended for intrathecal anaesthesia This is a single-use device.

Regulatory Flags#

DUNS number
118380146
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709207100BivonaXU26JS40NGE159N2026-10-22
10887709207117BivonaFU26JN60NSC161N2026-10-22
10887709207124BivonaFU26JN50NGC162N2026-10-22
10887709207131BivonaHU26JS70NSC158N2026-10-22
10887709207148BivonaFT26JN40NGF157N2026-10-22
10887709207155BivonaFT26JN35NGE140N2026-10-22
10887709207162BivonaFT26JN50NSF156N2026-10-22
10887709207179BivonaFT26JN65NSC160N2026-10-22
10887709207193BivonaFT26JN60NSC164N2026-10-22
10887709207209BivonaFT26JN35NGF165N2026-10-22
10887709207216BivonaAT26JS35NSA151N2026-10-22
10887709207223BivonaAT26JS40NSA150N2026-10-22
10887709207032BivonaFT26JN30NGE149N2026-10-21
10887709207049BivonaFT26JN35NGE148N2026-10-21
10887709207056BivonaFT26JN40NGE145N2026-10-21
10887709207063BivonaXU26JS50NSC147N2026-10-21
10887709207070BivonaFT26IN40NSF242N2026-10-21
10887709207087BivonaFU26JN60NGA155N2026-10-21
10887709207094BivonaFU26JN40NGF146N2026-10-21
10887709206905BivonaFU26JN40NSC136N2026-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048223122655Tuohy IIPajunk GmbH MedizintechnologieBSP2026-10-22
04048223122679Tuohy IIPajunk GmbH MedizintechnologieBSP2026-10-22
04048223122693Tuohy IIPajunk GmbH MedizintechnologieBSP2026-10-22
04048223122716Tuohy IIPajunk GmbH MedizintechnologieBSP2026-10-22
04048223122730Tuohy IIPajunk GmbH MedizintechnologieBSP2026-10-22
04048223122754Tuohy IIPajunk GmbH MedizintechnologieBSP2026-10-22
04048223122792Tuohy IIPajunk GmbH MedizintechnologieBSP2026-10-22
04048223122815Tuohy IIPajunk GmbH MedizintechnologieBSP2026-10-22
04048223122877Tuohy II NRFitPajunk GmbH MedizintechnologieBSP2026-10-22
04048223122891Tuohy II NRFitPajunk GmbH MedizintechnologieBSP2026-10-22
04048223122914Tuohy II NRFitPajunk GmbH MedizintechnologieBSP2026-10-22
04048223122938Tuohy II NRFitPajunk GmbH MedizintechnologieBSP2026-10-22
04048223122952Tuohy II NRFitPajunk GmbH MedizintechnologieBSP2026-10-22
04048223122976Tuohy II NRFitPajunk GmbH MedizintechnologieBSP2026-10-22
04048223122990Tuohy II NRFitPajunk GmbH MedizintechnologieBSP2026-10-22
04048223123010Tuohy II NRFitPajunk GmbH MedizintechnologieBSP2026-10-22
04048223123034Tuohy II NRFitPajunk GmbH MedizintechnologieBSP2026-10-22
04048223124574Tuohy II NRFitPajunk GmbH MedizintechnologieBSP2026-10-22
04048223124581Tuohy II NRFitPajunk GmbH MedizintechnologieBSP2026-10-22
04048223124611Tuohy IIPajunk GmbH MedizintechnologieBSP2026-10-22
04048223124628Tuohy IIPajunk GmbH MedizintechnologieBSP2026-10-22
04048223124635Tuohy IIPajunk GmbH MedizintechnologieBSP2026-10-22
04048223134030SonoPlex® II SuperCutPajunk GmbH MedizintechnologieBSP2026-08-27
04048223134054SonoPlex® II SuperCutPajunk GmbH MedizintechnologieBSP2026-08-27
04048223134078SonoPlex® II SuperCutPajunk GmbH MedizintechnologieBSP2026-08-27
04048223134092SonoPlex® II SuperCutPajunk GmbH MedizintechnologieBSP2026-08-27
04048223139110CauDal SonoPajunk GmbH MedizintechnologieBSP2026-07-06
04048223070499NerveGuard NRFitPajunk GmbH MedizintechnologieBSP2026-06-10
04048223076217Quincke NRFitPajunk GmbH MedizintechnologieBSP2026-06-10
04048223076248Quincke NRFitPajunk GmbH MedizintechnologieBSP2026-06-10